ARGUS / Dissolution Version 2 Dissolution Data Management Software

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1 ARGUS / Dissolution Version 2 Dissolution Data Management Software ARGUS/Dissolution Version 2 is a revolutionary scientific dissolution data management software tool for instrument control and advanced data acquisition, management, processing and reporting designed by users for users. Whether you perform dissolution tests occasionally or several times each day ARGUS/Dissolution Version 2 will make you more productive in running tests and analyzing results. ARGUS/Dissolution Version 2 simplifies how you collect and report dissolution test results by letting you choose the analysis template that matches the way you work. Whether you are in a QC department concerned about data security, compliance and validation, or need maximum flexibility in the R&D area, ARGUS/Dissolution Version 2 can help your lab perform more efficiently. Intuitive wizards help anyone in your lab work better your next dissolution test is running in just a few clicks. Bringing You Faster to Reliable Results Access dissolution data quickly using relational database technology Correct turbidity in your spectra at a second wavelength or by second derivative Analyze multi component drugs with models created by CAMO s The Unscrambler Drives spectrophotometers, baths and accessories of the market leaders Controls oflline sampling, online measurement, fiber optics and even multiple baths systems Allows seamless growth from single workstations to a dissolution laboratory network Designed for a data-secured regulatory lab environment ARGUS/Dissolution Version 2 allows you to multi-task without using multiple software packages. You can acquire data and control a variety of instruments, including baths, pumps, auto samplers and spectrophotometers. You can apply advanced calibration algorithms such as MCA and PLS with an instant display of calculated data. You can deploy methods and report templates for common use.

2 Maximize Productivity ARGUS/Dissolution Version 2 represents a fundamental shift in dissolution software usability. With its unique Analysis Tem-plate Technology, our software is designed for every user in your lab regardless of their task or skill level. Use the Analysis Wizard to complete parameter sets and run tests with minimal input or maximum flexibility. You can navigate the entire environment from the ARGUS/ Dissolution desktop, including instrument control, a real-time view of dissolution profiles, and a work area to recalculate raw data or to create reports. Review your data without the need of creating reports. Data is displayed in a What-you-see-is-whatyou-get fashion known from standard office applications. Additionally ARGUS/Dissolution provides a seamless integration of the process of applying electronic signatures. Exchange Data and Reports With raw data, methods and report templates stored centrally within the same database, you can easily share informationwith colleagues. Include only the details in the report you want. Even the language of the report can be chosen.export data into CSV and JCAMP-DX format to feed your dissolution profiles and spectra into thirdparty software. Copy & Paste from ARGUS/Dissolution into your office applications. Fig 2 Defining Roles in ARGUS/Dissolution Get More Information from Your Test ARGUS/Dissolution Version 2 works with full spectra, providing more reliable detection of scattering and making multi linear regression models possible resulting in more accurate multi-component analysis. Dissolution Calculations ARGUS/Dissolution Version 2 has already built-in calculations that corrects for volume changes and mass loss. With this all-in-one approach, time consuming and error-prone transcription of data collected from various sources into spreadsheets will be a thing of the past. Forge Your Automatic Cleaning Porgram ARGUS/Dissolution Version 2 let you translate your experience with best cleaning procedures into a permanent program. If the Hanson AutoPlusTM MAXIMIZERTM is employed cleaning tubing and flow-through cells of an online dissolution system with multiple baths is reliably accomplished with a simple click. Fig 1 Main screen of ARGUS/Dissolution Compliance Maintaining regulatory compliance is easy with ARGUS/ Diss lution Version 2. With the System Qualification Wizard you can schedule your next qualification tasks. Validation protocols covering software, spectrophotometer, baths and accessories are available for systems driven with ARGUS/Dissolution. ARGUS/Dissolution Version 2 automatically creates detailed audit trails to record changes of methods, analyses, system configurations and other relevant data. Every entry is identified with the date and time of the modification together with the operator s name. Secure system authentication ensures that only valid users are able to access the system. Permissions for each action can be combined into roles that represent method developers, system administrators, operators or whatever is required in your working environment. As a system administrator you can assign one or more role to each individual user. Enhanced Data Management From instrument control to final reports, ARGUS/Dissolution Version 2 manages all your data needs and makes your lab more productive. No matter what type of lab you are working in, you focus your time on science, not on data transcription or file management. The strength of ARGUS/Dissolution Version 2 is its reliability. It collects and stores test results, automatically linking system configuration and method parameter with each dissolution test It connects data and any modification applied afterwards with the identity of the operator using the computer system It logs relevant events, errors or login failures Future-Proof Technology Built on industry standards, developed according to regulations and guidance set forth in 21CFR Part11 and GAMP, ARGUS/Dissolution Version 2 is designed to be your versatile tool to manage your lab s dissolution test workload while reducing your validation effort to a minimum. Whether you need to control a single bath or support dissolution workflows that span the entire laboratory and even offices, ARGUS/Dissolution Version 2 offers the right

3 configuration for you. The database can run on a single work-station or on a server. You can easily add new clients to both and migrate from a standalone system to a dissolution laboratory network. Drive the Equipment That You Need ARGUS/Dissolution Version 2 drives almost all dissolution equipment of any vendor on the market. You can choose your favorite baths, pumps, spectrometers and accessories and build the dissolution system you need or advance existing devices to automated systems at minimal cost. Spectroscopy System Fig 3 Spectroscopy System with XYZ-Auto Sampler This configuration is designed for sample analysis by means of UV/Vis. Whether you withdraw your aliquots by hand or automatically with an offline system ARGUS/Dissolution Version 2 provides the appropriate counterpart to continue your dissolution test workflow with only a few clicks. Arrange sample sequences from various baths on your xyz-auto sampler for unattended analysis. Spectra are automatically linked to your analysis dataset with instant calculation of dissolution values. Offline System This configuration is designed for systems of one or more baths that do automated sampling into vials for offline analysis by HPLC or UV/Vis. With AR-GUS/Dissolution Version 2 you can drive your dissolution test system and monitor stirrer speed, temperature, sampling, sampled volume and other events required for an accurate calculation of dissolution results. You can easily process these raw data into a report or add analytical data as they arrive. Online UV/Vis System This configuration is designed for unattended withdrawal and analysis of samples which recently became indispensable whenever dissolution profiles are required or when the throughput of your bath should be high even during the night or on weekends. The Cutting Edge Application Software for Pharmaceutical Dissolution Testing Fiber-Optic System This configuration is designed for in-situ analysis in the vessel. ARGUS/Dissolution Version 2 copes with the challenges of multi-channel fiber optic measurement and allows data collection rates limited only by the capabilities of the spectrometer. Data Client This configuration is designed for in-situ analysis in the vessel. ARGUS/Dissolution Version 2 copes with the challenges of multi-channel fiber optic measurement and allows data collection rates limited only by the capabilities of the spectrometer. Multiple Baths Adding a second or a third bath to your dissolution system can be done with a minimum of fuss. Even if it is another make and model ARGUS/Dissolution Version 2 will simply incorporate it into the new configuration and reliably detect sampling time collisions - before the pill drops. Analyze Combination Drugs in One Effort You wish to analyze two or more active ingredients in one drug without the cost and time overhead of HPLC analysis but with maximal convenience and automation? ARGUS/ Dissolution Version 2 has the chemometric power. You have the choice between multilinear regression or even more sophisticated models like PLS created with the well known CAMO The Unscrambler. With the intuitive one-stop design of ARGUS/Dissolution Version 2 handling of these calibration models is straightforward and as easy as applying common calibration types. Fig 4 Online Prediction with PLS2 Model

4 Enterprise Integration ARGUS/Dissolution is based on the reliable ARGUS platform which seamlessly integrates dissolution testing into your corporate environment, e.g. LIMS. Exchange methods and analyses between development and QC laboratories. ARGUS/Dissolution is compatible to your existing dissolution testers and also integrates additional hardware such as spectrophotometers. The client-server architecture of the ARGUS platform perfectly fits into your corporate network. Features Usability Wizard access to major functions Full keyboard control Tooltips and context sensitive online help Document search capabilities Analysis template technology Emergency stop capability English and German user interface Detection of possible timing problems Real time dissolution profiles Customizable report templates WYSIWYG method- and analysis display Raw data export (Excel or JCAMP-DX) Power and lamp saving functions Multiple bath configurations Programmable cleaning procedures Analytical Capabilities Full spectrum support Peak picking on all spectra charts Savitzky-Golay second derivative Turbidity baseline Placebo effect elimination ARGUS/Dissolution controls your dissolution tester hardware. Data is acquired from all devices you use in your dissolution test setup, including bath, spectrometer and pump. Methods and analyses are retrieved from and stored to the documents database. Connect multiple dissolution test laboratories to one central database ARGUS/Dissolution can be used off-line to query, review, approve, release and electronically sign methods and analyses. Use ARGUS/Dissolution to exchange data with your LIMS or enterprise document management system (EDMS). Query or browse methods, analyses and other data by using any standard webbrowser. ARGUS/Dissolution runs on a Java Virtual Machine which makes the application secure and extremely stable as required in highly regulated GxP environments. With the ARGUS Software Deployment Server centralized deployment and version control is easily accomplished. If you are already running the stand-alone version of ARGUS/Dissolution migration to an enterprise version is always possible. All data (methods, analyses, ) can easily be transferred. A11 Concentration curve Multi Component Analysis CAMO The Unscrambler model support Recalculation of analyses Statistics (ph, temperature, dissolution) Infinity test Automated media change USP and Pharm. Eur. Acceptance One or more Q-values for each API High/low dissolution boundaries USP S1, S2 and S3 testing in one record 21 CFR Part 11 Detailed audit trail for electronic records System log for tracking application events Electronic signature support Cryptographical record protection Role specific access to program functions IQ/OQ/PQ support with reminder function Built in system suitability check Failsafe technology for data recovery

5 Groupware Functionality (Enterprise Edition) Method deployment via shared database Centralized user account management Prepared for LIMS connectivity Review Data from different clients Spectrophotometer Driver Agilent 8453; Beckman DU800; Kontron Uvikon XL; PerkinElmer LAMBDA 2/20/25/35/45; Pharma Test SA500; Shimadzu UV1700 PharmaSpec; Tec5 MultiSpec; Thermo Evolution 300; Tidas II (9-channel fiber optic); Varian Cary50; Zeiss MCS5XX (2-channel fiber optic) Dissolution Tester Driver Hanson SR8 Plus; Pharma Test PTWS/IDS1000; Sotax AT7/AT7 smart; Varian VK70XX; Distek 2100, 5100, Evolution series; ERWEKA DT800 Pump Driver Hanson AutoPlus MAXIMIZER; Hamilton Dynamix III; ISMATEC IPC-N; Sotax CY-7-50; Varian Vk806; Watson Marlow 323Du; Distek Evolution 4300 Autosampler & Fraction Collector Driver Hanson AutoPlus MultiFill; PerkinElmer AS90, AS93plus; Sotax C613/C615; Varian Vk8000; Distek Evolution 4300 Drivers available on demand Agilent 8452A; AnalyticJena SPECORD 200/205/210/250; Beckman Du600; Copley Scientific Dissolution Tester; Distek 2230A System Requirements 256 MB RAM recommended minimum 200 MB hard disk space recommended minimum (includes space required during installation) Intel Pentium III or compatible at 800 MHz or better (single core) CD-ROM drive (only for installation) High-resolution monitor (1024x768 or higher, 256 colors or better) Mouse or other pointing device Serial port, PCI slot, ethernet port (the number of ports needed depends on the instruments used) Microsoft Windows 2000, XP or Vista Adobe Acrobat Reader (to view manual) Get a Free Demo More details on ARGUS/Dissolution, a list of supported instruments and sample reports are available for download at our website To receive a free demo disc or to contact a product specialist send an to software@solvias.com or ask your system vendor.

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